All-in one syringe assembly for blood draws and medicine delivery to patients

ABSTRACT

A syringe assembly includes (i) a syringe with a cylindrical body, luer tip at a first end, finger grip at a second end and a cannula extending from the luer tip into the cylindrical body, and (ii) a plunger unit having an adapter portion, receiving cavity, finger grip and piston. A channel extends the length of the adapter portion to receive the cannula in one end and a variety of connectors, valves and/or syringes in a second end. The end of the channel accessible in the receiving cavity mates with or engages any number of commercially available valves, connectors and/or syringes while the luer tip similarly connects to any number of valves, catheters, connectors, etc., depending on the task being undertaken with the syringe assembly.

CROSS-REFERENCE

This application is a division of and claims priority to U.S. patentapplication Ser. No. 16/872,265 filed May 11, 2020 which claims priorityto U.S. Provisional Application No. 62/845,767 filed May 9, 2019, andU.S. Provisional Application No. 62/909,669, filed Oct. 2, 2019 thecontents of each incorporated herein by reference.

FIELD OF THE INVENTION

The embodiments of the present invention relate generally to medicalsyringe assembly for withdrawing fluid from a patient and injectingmedicines into a patient whereby the syringe is configured to (i)minimize contamination and hemolysis in the fluids; (ii) reduce timeneeded to undertake tasks; and (iii) reduce items needed to undertaketasks.

BACKGROUND

Blood samples for testing may be collected from patients using manydevices. Many such collections currently utilize a syringe including acylindrical body and a plunger assembly. The cylindrical body has aninterior wall, an open proximal end, a closed distal end, and a distalopening through the distal end. A hypodermic needle or indwellingcatheter may be provided on, or attached to, the distal endcommunicating with the distal opening.

Unfortunately, the current syringes having cylindrical bodies andplunger assemblies suffer from drawbacks, including unsatisfactory (i)connector performance and adaptability; (ii) cannula position andattachment; (iii) plunger design; and (iv) related design shortcomings.

Thus, it would be advantageous to develop a syringe having a cylindricalbody and a plunger assembly which overcomes the noted drawbacks.Furthermore, it would be advantageous to develop such a syringe that canbe pre-filled with a medicine or flush as needed.

SUMMARY

The embodiments of the present invention first include a syringe havinga generally cylindrical body with a first end for mating to a connectorand a second, spaced open end for receipt of a plunger unit. A fingergrip extends radially outward from the second open end. In oneembodiment, the finger grip is a pair of oppositely extending flangesformed integrally with the syringe. A cannula extends from the first endto a point within the cylindrical body near the second open end.

The embodiments of the present invention next include a plunger unitadapted to slidably insert into the cylindrical body of the syringe. Anadapter portion of the plunger unit is slidably disposed in thecylindrical body of the syringe. A piston on the end of the adapterportion of the plunger unit sealably engages an interior wall of thecylindrical body thereby defining a dynamic fluid chamber between an aftsurface of the piston and an inner surface of the first end of thecylindrical body. A channel in the adapter portion of the plunger unitreceives the second end of the cannula. A second portion of the plungerunit comprises a receiving cavity. In one embodiment, the receivingcavity is a generally cylindrical body extending from, and integralwith, the adapter portion of the plunger unit. A finger grip may extendradially outward from an open end of the receiving cavity. In oneembodiment, the diameter of the receiving cavity is greater than thediameter of the syringe so as to receive numerous different devicesincluding vacutainers.

A needle-free valve is positioned partially within the plunger unitchannel and extends into the receiving cavity. The needle-free valveserves to seal the channel from the retrograde flow of air and mayengage a specimen tube, syringe or other device. The valve may take onmany forms and purposes as detailed below.

As configured, the adapter portion of the plunger unit is free to movewithin the cylindrical body of the syringe as guided by the piston andcannula. Friction created by the piston engaging the cylindrical body ofthe syringe provides slight resistance against movement of the plungerunit and maintains the plunger unit in place when no external force isapplied. Locking mechanisms may be incorporated to lock the plunger unitrelative to the syringe into which it is inserted.

Other variations, embodiments and features of the present invention willbecome evident from the following detailed description, drawings andclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of a syringe assembly according to theembodiments of the present invention;

FIG. 2 illustrates one embodiment of a plunger unit according to theembodiments of the present invention;

FIG. 2A illustrates a cross-sectional view of a plunger unit with glueslots according to the embodiments of the present invention;

FIG. 2B illustrates an end view of the plunger unit with glue slotsaccording to the embodiments of the present invention;

FIG. 3 illustrates a side view of one embodiment of a syringe accordingto the embodiments of the present invention;

FIG. 4 illustrates an end view of the first end of the syringe of FIG. 3according to the embodiments of the present invention;

FIG. 5 illustrates the first end of the syringe of FIG. 3 with a cannulain position according to the embodiments of the present invention;

FIG. 6A illustrates the syringe of FIG. 3 with a cut-away area to freelyobserve the cannula extending into the first end of the syringeaccording to the embodiments of the present invention;

FIG. 6B illustrates a syringe with a recessed cannula according to theembodiments of the present invention;

FIG. 6C illustrates the syringe of FIG. 6B proximate a connector with aspike according to the embodiments of the present invention;

FIG. 6D illustrates the syringe of FIG. 6B mated with the connector ofFIG. 6C according to the embodiments of the present invention;

FIG. 7 illustrates a syringe assembly with a locking blunt cannulaadaptor according to the embodiments of the present invention;

FIGS. 8 and 8A illustrate side and top views of a first alternativereceiving cavity design according to the embodiments of the presentinvention;

FIG. 9 illustrates the first alternative receiving cavity design with alocking blunt cannula adaptor in place according to the embodiments ofthe present invention;

FIGS. 10 and 10A illustrate side and top views of a second alternativereceiving cavity design according to the embodiments of the presentinvention;

FIG. 11 illustrates the second alternative receiving cavity design witha locking blunt cannula adaptor in place according to the embodiments ofthe present invention;

FIGS. 12 and 12A illustrate side and top views of a third alternativereceiving cavity design according to the embodiments of the presentinvention;

FIG. 13 illustrates the third alternative receiving cavity design with alocking blunt cannula adaptor in place according to the embodiments ofthe present invention;

FIG. 14 illustrates one embodiment of the syringe assembly connected toa vacutainer housing according to the embodiments of the presentinvention;

FIG. 15 illustrates one embodiment of the syringe assembly connected toa collection vile according to the embodiments of the present invention;

FIG. 16 illustrates one embodiment of the syringe assembly connected toa flush syringe according to the embodiments of the present invention;

FIG. 17 illustrates one embodiment of the syringe assembly connected toa PhaSeal™ connector according to the embodiments of the presentinvention;

FIG. 18 illustrates one embodiment of the syringe assembly connected toa Texium™ connector according to the embodiments of the presentinvention;

FIG. 19 illustrates one embodiment of the syringe assembly connected toa Spiros™ connector according to the embodiments of the presentinvention;

FIG. 20A illustrates a first view of a syringe assembly with a cannulawithin a cannula design according to the embodiments of the presentinvention;

FIG. 20B illustrates a second view of a syringe assembly with a cannulawithin a cannula design according to the embodiments of the presentinvention;

FIG. 20C illustrates a third view of a syringe assembly with a cannulawithin a cannula design according to the embodiments of the presentinvention;

FIG. 21A illustrates a first view of a syringe assembly with a lockingmechanism according to the embodiments of the present invention;

FIG. 21B illustrates a second view of a syringe assembly with a lockingmechanism according to the embodiments of the present invention;

FIG. 22A illustrates an end view of the syringe showing side portsaccording to the embodiments of the present invention;

FIG. 22B illustrates a side view cross-sectional view of the syringeshowing the side ports according to the embodiments of the presentinvention;

FIG. 23A illustrates a first view of an external locking mechanismaccording to the embodiments of the present invention;

FIG. 23B illustrates a second view of an external locking mechanismaccording to the embodiments of the present invention;

FIG. 23C illustrates a third view of an external locking mechanismaccording to the embodiments of the present invention;

FIG. 23D illustrates a fourth view of an external locking mechanismaccording to the embodiments of the present invention;

FIG. 23E illustrates a fifth view of an external locking mechanismaccording to the embodiments of the present invention;

FIG. 23F illustrates a sixth view of an external locking mechanismaccording to the embodiments of the present invention;

FIG. 24A illustrates a first view of an internal locking mechanismaccording to the embodiments of the present invention;

FIG. 24B illustrates a second view of an internal locking mechanismaccording to the embodiments of the present invention;

FIG. 24C illustrates a third view of an internal locking mechanismaccording to the embodiments of the present invention;

FIG. 24D illustrates a close view of flanges of an internal lockingmechanism according to the embodiments of the present invention;

FIG. 24E illustrates a tapered cylindrical syringe body acting as aplunger unit lock according to the embodiments of the present invention;

FIG. 24F illustrates the tapered cylindrical syringe body with theplunger unit moved according to the embodiments of the presentinvention;

FIG. 25A illustrates a fluid de-accelerator insert positioned within amale luer tip according to the embodiments of the present invention;

FIG. 25B illustrates a first fluid de-accelerator insert according tothe embodiments of the present invention;

FIG. 25C illustrates a second fluid de-accelerator insert according tothe embodiments of the present invention;

FIG. 26 illustrates a first method facilitated by the syringe assemblyembodiments of the present invention;

FIG. 27 illustrates a second method facilitated by the syringe assemblyembodiments of the present invention;

FIG. 28 illustrates a third method facilitated by the syringe assemblyembodiments of the present invention;

FIG. 29 illustrates a fourth method facilitated by the syringe assemblyembodiments of the present invention;

FIG. 30A illustrates a first means for reducing fluid entering into aplunger unit channel according to the embodiments of the presentinvention; and

FIG. 30B illustrates a second means for reducing fluid entering into aplunger unit channel according to the embodiments of the presentinvention.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles inaccordance with the embodiments of the present invention, reference willnow be made to the embodiments illustrated in the drawings and specificlanguage will be used to describe the same. It will nevertheless beunderstood that no limitation of the scope of the invention is therebyintended. Any alterations and further modifications of the inventivefeature illustrated herein, and any additional applications of theprinciples of the invention as illustrated herein, which would normallyoccur to one skilled in the relevant art and having possession of thisdisclosure, are to be considered within the scope of the inventionclaimed.

The individual parts of the syringe assembly may be fabricated of anysuitable materials including but not limited to polymers, alloys,metals, composites and combinations thereof. The individual parts of thesyringe assembly may be fabricated using any suitable manufacturingtechniques, including but not limited to molding, casting, additiveprinting, forming and combinations thereof.

FIG. 1 shows one embodiment of a syringe assembly 100 according to theembodiments of the present invention. In general, the syringe assembly100 includes (i) a syringe 105 comprising a cylindrical body, luer tip110 at a first end, finger grip 115 at a second end and a cannula 120extending from the luer tip 110 into the cylindrical body, and (ii) aplunger unit 200 comprising an adapter portion 205, receiving cavity210, finger grip 215 and piston 220.

As shown in FIG. 1, a valve 225 engages one end of a channel 206extending the length of the adapter portion 205. In one embodiment, thechannel 206 is tapered along its length in a decreasing manner from thereceiving cavity 210 to the cannula 120. The second end of the channel206 receives the cannula 120. As shown herein, the end of the channel206 accessible in the receiving cavity 210 accommodates any number ofcommercially available valves depending on the task being undertakenwith the syringe assembly 100.

FIG. 2 shows the plunger unit 200 disengaged from the syringe 105. Inone embodiment, the adapter portion 205, receiving cavity 210 and fingergrip 215 are a single integral item. For example, the adapter portion205, receiving cavity 210 and finger grip 215 may be collectivelyfabricated using a single mold. Alternatively, the adapter portion 205,receiving cavity 210 and finger grip 215 may be fabricated individuallyand thereafter connected to one another. In one embodiment, the adapterportion 205 has an X-cross-section comprising four equally spaced ribsextending the length of the adapter portion 205. In one embodiment, thedepth (D) of the receiving cavity 210 is between about 1 inch to about1.5 inches permitting easy access to any valve (e.g., closed luer valve)engaged with the end of the channel 206 within the receiving cavity 210.In one embodiment, the valve attaches in the channel 206 in thereceiving cavity 210 by means of a friction fit. Alternatively, thevalve may be adhered to the receiving cavity at the channel 206 usingadhesive, such as glue. FIGS. 2A and 2B show glue slots 223 for receiptof glue to attach a valve to the plunger unit 200. In one embodiment,the glue slots 223 have a range of dimensions of about0.010″−0.250″×005″−0.015″×005″−0.050″. In one embodiment, surfaces areEDM finished or acid etched to desired depths and to roughen thesurface.

In one embodiment, piston 220 is fabricated of Santoprene 8281-55MED orsimilar material to create enough seal with the inner surface of thecylindrical body of the syringe 105 preventing push back of fluid.

FIGS. 3 through 6A show the syringe assembly 100 according to theembodiments of the present invention. The syringe assembly 100incorporates a cannula 120 extending substantially flush with an exitopening 111 in luer tip 110. FIG. 6 shows a cut-away view clearlydepicting the position of the cannula 120 substantially flush with theopening 111 at the luer tip 110.

In one embodiment, the cannula 120 is recessed rearward of the openingin the luer tip 110. The recess provides the syringe assembly 100compatibility with certain connectors, namely needlefree connectors,luer-activated valves and IV connectors which may have an internal spikeor similar projection intended to insert into the luer tip 110 forfunctionality. Examples are the Clave® or MicroClave® made by ICUMedical, Inc., Invision Plus® made by Rymed and OneLink® made by Baxter.Such devices connect to various peripherally inserted central catheters,central lines and peripheral lines. By recessing the carmula 120, spaceis available to accommodate the spike or similar projection in the luertip 110. In one embodiment, the cannula 120 is recessed between about0.15 inches to about 0.35 inches from the opening 111 in the luer tip110.

FIGS. 6B-6D show a syringe 102 of the type used with the embodiments ofthe present invention. In this instance, syringe 102 has a recessedcarmula 122 as best seen in FIG. 6B. A connecter 126 having a spike 128is shown proximate the syringe 102 in FIG. 6C and inserted into thesyringe 102 in FIG. 6D. Without the recessed cannula 122, connector 126would not be able to mate with syringe 102 and function with thecorresponding syringe assembly.

The cannula 120 has a cross-section smaller than the opening 110 at thetip thereby allowing fluid to flow between the outer surface of thecannula 120 and the inner surface of the opening into the fluid chamber130 defined by an aft surface of the piston 220 and an inner surface ofthe luer end of the syringe 105. In one embodiment, the cannula 120 issecured to the luer tip 110 via one or more flanges, struts, wings,beveled flange, net fit or other mechanical structures (not shown)extending between the inner surface of the luer tip 110 and the outersurface of the cannula 120. The one or more flanges, struts or othermechanical structures should not impede the flow of fluids extendingbetween the inner surface of the luer tip 110 and the outer surface ofthe cannula 120. In another embodiment, the cannula 120 is secured tothe luer tip 110 using self-curing adhesives, UV curing, thermal bondingor may be molded in place, insert molded or over molded or otherwisebonded. Those skilled in the art will recognize that the cannula 120 maybe attached to the inner surface of the luer tip 110 using any meansavailable as long it does not interfere with the operation of thesyringe assembly 100 as described herein. As used herein, “secured” doesnot equate to unmovable, as a certain amount of over pressure can causethe cannula 120 to dislodge from the luer tip.

In one embodiment, the syringe 105 incorporates a luer tip 110 isfabricated to comply with ISO Luer Standard 80369-7. ISO 80369-7 isspecifically for small-bore connectors intended to be used asintravascular connections in intravascular applications or hypodermicconnections in hypodermic applications of medical devices and relatedaccessories such as syringe 105. The luer tip 110 and thread isconfigured to cooperate with connectors having center post designs andlocking and non-locking cannula adaptors. FIG. 7 shows the syringeassembly 100 with a locking blunt cannula adaptor 150 attached accordingto the embodiments of the present invention. The locking blunt cannularadaptor 150 allows the syringe assembly to access pre-slit connectordesigns.

FIGS. 8-13 show various embodiments of a syringe assembly having aclosed luer valve in place of an open luer valve. FIG. 8 shows a syringeassembly 100′ including (i) a syringe 105′ comprising a cylindricalbody, luer tip 110′ at a first end, finger grip 115′ at a second end anda cannula 120′ extending from the luer tip 110′ into the cylindricalbody, and (ii) a plunger unit 200′ comprising an adapter portion 205′,receiving cavity 210′ with channel 206′, finger grip 215′ and piston220′. The syringe assembly 105′ further incorporates a closed luer valve230 and window 212 in the receiving cavity 210. FIG. 10 shows a syringeassembly 100″ including (i) a syringe 105″ comprising a cylindricalbody, luer tip 110″ at a first end, finger grip 115″ at a second end anda cannula 120″ extending from the luer tip 110″ into the cylindricalbody, and (ii) a plunger unit 200″ comprising an adapter portion 205″,receiving cavity 210″, finger grip 215″ and piston 220″. The syringeassembly 105″ further incorporates a closed luer valve 230′. FIG. 12shows a syringe assembly 100′″ including a (i) a syringe 105′″comprising a cylindrical body, luer tip 110′″ at a first end, fingergrip 115′ at a second end and a cannula 120′″ extending from the luertip 110′″ into the cylindrical body, and (ii) a plunger unit 200′comprising an adapter portion 205′, receiving cavity 210′″, finger grip215′″ and piston 220′″. The syringe assembly 105′ further incorporates aclosed luer valve 230′. FIGS. 9, 11 and 13 show syringe assemblies 105′,105″ and 105′″ with a blunt cannula locking adapter 150′ 150″ and 150″in place.

FIG. 14 shows syringe assembly 100 positioned for receipt of avacutainer housing 250 into receiving cavity 110 where valve 255,engaged with channel 206, connects to the vacutainer housing 250. FIG.15 shows the vacutainer housing 250 in place via attachment to valve 255and a collection vile 260 inserted into the vacutainer housing 250. Anaccess port 265 is also shown attached to the luer tip 110 forfacilitating a blood draw via a PICC line or like device. FIG. 16 showssyringe assembly 100 with a flush syringe 270 attached directly to thechannel 206 to allow flushing of the line.

FIG. 17 shows the syringe assembly 100 having valve 320 (inside thereceiving cavity 210) connected to a PhaSeal™ connector 275 from BD (akaBecton, Dickinson and Company). FIG. 18 shows the syringe assembly 100having valve (inside the receiving cavity 210) 321 connected to aTexium™ connector 280 from BD. FIG. 19 shows the syringe assembly 100having valve 322 (inside the receiving cavity 210) connected to aSpiros™ connector 285 from ICU Medical.

FIGS. 20A-20C illustrate a syringe 300 with a cannula 305 within acannula 310 design according to the embodiments of the presentinvention. In this embodiment, cannula 305 is positioned within securedcannula 310 and attached to the plunger unit 315. When the plunger unit315 is depressed cannula 305 advances into and through, for example, apatient's IV peripheral catheter and into the vein. In one embodiment,pre-filled saline/solution acts and aids in the insertion process as thesaline/solution “floats” the advancing cannula 305 into the catheter andvein. In such an embodiment, as the plunger unit 315 is depressed, theinternal cannula 305 is advanced while simultaneously the plunger unit315 infuses fluid from the syringe with the internal cannula 305 as itenters the vein. This may also be accomplished by utilizing a salinesyringe attached to a valve in the receiving cavity of the plunger unit.Once the successful placement of the internal cannula 305 is achieved, avacutainer with vacuum tubes or a syringe can be attached to the valvefor blood or fluid sampling. Once sampling is concluded, a flush syringecan be attached to the valve for flushing per facility protocol. Once afinal flush is completed, the cannula 305 is retracted into cannula 310or encapsulated into an expandable housing by manual, mechanical,pressure and/or vacuum assist. FIG. 20B shows the cannula 305 insertedinto a catheter 320 while FIG. 20C shows the cannula 305 relative to acatheter 325.

FIGS. 21A-21B illustrate a syringe assembly 400 with a locking mechanism401 according to the embodiments of the present invention. The lockingmechanism 401 serves to maintain plunger unit 410 in place at variouspositions relative to the syringe 405. The locking mechanism 401 alsoserves to maintain the plunger unit 410 in a fully retracted position.In this embodiment, one or more raised catches 402 on a finger grip 415of the syringe 405 capture one or more outward extending flanges 411 onthe adapter portion 406 of the plunger unit 410 when the plunger unit410 is rotated at the appropriate position within the syringe 405locking the plunger unit 410 in place. In one embodiment, the syringeassembly 400 may have flanges 411 extending from opposite sides and thesyringe finger grip 415 which has two raised catches 420 positioned, sothat when the plunger unit 410 is rotated, the two flanges 411 arecaptured by the two raised catches 420.

In one embodiment, the syringe of the various syringe assemblies may bepre-filled with a flush, medicament or other fluid. In such anembodiment, the dimensions of side ports 123-1 and 123-2 as shown inFIGS. 22A and 22B are selected to provide a decreased pull pressure,prevent cell damage to ingested blood fluids, and facilitate pre-fillingthe fluid chamber. In other words, the size of the side ports 123, oneither side of the central opening, is determined to permit proper fluidflow in and out of the syringe and may also provide means forpre-filling the syringe. The syringe can be filled utilizing a luerattached to the channel in the receiving cavity that receives a flushsyringe. BY clamping the line, the contents when forced out of the flushsyringe through the cannula into the clamped line are forced to backfill the syringe via the side ports. The contents of the syringe may nowbe used to flush the line. This again reduces the need to change ortouch the main connection between the syringe assembly and the line intothe patient.

FIGS. 23A-23F show an external locking mechanism 500 according to theembodiments of the present invention. The locking mechanism 500 includesan opening 505 and internal slot 510 to slide over the finger grip 515of the syringe 530. The slot 510 (best seen in the cross-sectional viewsof FIGS. 23E and 23F) permits the locking mechanism 500 to slide (seearrow A) on the finger grip 515. Once in position, the opening 505allows the plunger unit 525 to insert into the syringe 530. One or morecut-outs 535 in the plunger unit 525 serve to selectively lock theplunger unit 525 in place relative to the syringe 530 when an uppersurface of the locking mechanism 500 defining the slot 510 is receivedby one of the cut-outs 535 thus locking the plunger unit 525 in place.

FIGS. 24A-24D show an integral locking mechanism according to theembodiments of the present invention. Locking mechanism locks theplunger unit 610 in place relative to the syringe 615. In this instance,the locking mechanism is formed in part on both the plunger unit 610 andthe syringe 615. As best seen in FIG. 24A and the top view of FIG. 24B,the cylindrical body of the syringe 615 includes a pair of oppositelypositioned slots 620-1 and 620-2 in a finger grip 625 thereof. A pair ofprojections or flanges 630-1 and 630-2 (best seen in FIGS. 24C and 24D)in the plunger unit 610 are configured and positioned to slide intoupper segments 621-1 and 621-2 of the slots 620-1 and 620-2,respectively, and upon rotating the plunger unit 610, the projections630-1 and 630-2 slide along the horizontal portions 622-1 and 622-2 ofthe slots 620-1 and 620-2 thereby locking the plunger unit 610 inposition. Unlocking the plunger unit 610 comprises rotating the plungerunit 610 in the opposite direction and pulling the plunger unit 610upward relative to the syringe 615.

In another embodiment, as shown in exaggerated fashion in FIGS. 24E and24F, the cylindrical body 655 of the syringe 660 is tapered smaller awayfrom the luer tip 665 so that the plunger unit 670 is effectivelyprevented from exiting the syringe 660 due to friction between theplunger unit piston 675 and inner wall of the cylindrical body 655 ofthe syringe 660. As designed and dimensioned, and as shown in FIG. 24F,the plunger unit piston 675 is able to reach near the top of thecylindrical body 655 with normal pull pressure by a user but ultimatelythe friction prevents further displacement (i.e., locks the plunger unitpiston in position near the top opening of the syringe). While shown ina tapered configuration, the piston 675 may be circular or any othershape desired. In this embodiment, by locking the plunger unit 675 in afully extended position, a vacuum is generated permitting the infusionof a medication (e.g., de-clotting agent) through a valve connectedwithin the receiving cavity so that the vacuum draws the de-clottingagent into the clotted area within the catheter/central line orperipherally inserted central line (PICC).

FIGS. 25A-25C show a fluid de-accelerator insert 700 according to theembodiments of the present invention. As shown, the fluid de-acceleratorinsert 700 can take on various shapes and dimensions. As shown in FIG.25B, a first design 700-1 is a dual circuit double helix design. Asshown in FIG. 25C, a second design 700-2 is a single circuit cross-overdesign. In either instance, the fluid de-accelerator insert 700 ispositioned, as shown in FIG. 25A, within the luer of the syringeassembly proximate the secured cannula. The insert serves to controlfluid flow into and out of the syringe via side ports. As fluid passesabout the circumferences of the inserts it is slowed by the various pathdesigns. Those skilled in the art will recognize that other designs areconceivable.

The embodiments of the present invention facilitate a series of methods.A first method detailed in flow chart 900 of FIG. 26 relates to a singleIV/arterial access closed system blood collection system. This systemreduces multiple accesses to a catheter connector to a single access. Inthis embodiment, the syringe includes access for insertion of avacutainer holder to withdraw blood. At 905, attach the syringe assemblyaccording to the embodiments of the present invention to a catheter orIV connector on a catheter or Y site access. At 910, a plunger unit ispulled back to aspirate and draw Heparin or blood or medications intothe syringe chamber to clear the catheter (i.e., check patency). At 915,a vacutainer or syringe is attached by rotating and locking onto thevalve in the receiving cavity. At 920A, if utilizing a vacutainer,insert blood collection vacuum tubes to obtain samples or, at 920B, ifutilizing a syringe, use the syringe to withdraw until a desired volumeis achieved. At 925, remove the vacutainer or syringe and re-infuseHeparin or blood or medications into patient. At 930, attach a flushsyringe and infuse per facility protocol. At 935, remove syringe frompatient and discard per hospital protocol.

A second method detailed in flow chart 1000 of FIG. 27 relates to asyringe assembly pre-filled with a flush solution. At 1005, attach thesyringe assembly according to the embodiments of the present inventionto a catheter or IV connector on a catheter or Y site access. At 1010,check patency by pulling back on plunger unit. At 1015, a vacutainer orsyringe is attached by rotating and locking onto the valve. At 1020A, ifutilizing a vacutainer, insert blood collection vacuum tubes to obtainsamples or at 1020B, if utilizing a syringe, use the syringe to withdrawuntil a desired volume is achieved. At 1025, optionally remove thevacutainer or syringe. At 1030, depress plunger unit to infusepre-filled flush solution. At 1035, remove syringe from patient anddiscard per hospital protocol.

The versatility of the syringe assembly according to the embodiments ofthe present invention permits aspiration and administration with anyneedleless connector and any closed system transfer device utilizingmale/female components thus bypassing steps that are subject to uservariances and exposure to a growing list of hazardous drugs. The syringeassemblies according to the embodiments of the present invention areideal for handling hazardous drugs because the syringe assemblies arecompatible with all needleless connectors, all female luer hubs (e.g.,peripheral IV catheters, single, double and triple lumen lines,stopcocks and manifolds, T-connectors, etc.), needle free connectors,intravenous push of hazardous drugs, syringes containing a hazardousdrug with a closed system transfer device can be safely disconnectedfrom a mating needleless connector allowing a flush to be connected fora complete intravenous drug push.

The syringe assemblies according to the embodiments of the presentinvention (i) may be used with all needle free connectors, catheters andclosed system transfer devices; (ii) provide single access that preventsdesign related contamination of the needle free connector known toincrease with multiple accesses (can help hospitals achieve optimalcentral line associated blood stream infection; (iii) validate patencyduring hazardous drug administration; and (iv) prevent hazardous drugexposure by eliminating intravenous push administration of hazardousdrugs that require immediate flush to ensure complete dose is flushedand line is clear of blood.

Single access minimizes potential contamination to the internalstructure of the valve resulting in multiple changes or risks to centralline associated blood stream infection rates which affect hospital CMSreimbursement. The current procedure comprises (i) disinfect; (ii)access with flush syringe; (iii) de-access; (iv) disinfect; (v) attachmedication; (vi) detach; (vii) disinfect; (viii) attach flush; (ix)detach disinfect; (x) attach lock and (xi) detach. With currentinvention the procedure comprises: (i) disinfect; (ii) attach; (iii)utilize as needed and (iv) detach.

Moreover, the instant syringe assemblies accommodate administration ofhazardous drugs in compliance with USP800 regulations because it iscompatible with all needleless connector components and any female luerhubs, needle free connectors and closed system transfer devices may beadded for safe transport, patency check and intravenous push ofhazardous drugs, syringes containing hazardous drugs with a closedsystem transfer device can be safely disconnected from mating needlelessconnector, flush syringe can then be applied for complete delivery ofintravenous push medication and safe removal of the syringe system.

A third method detailed in flow chart 1100 of FIG. 28 relates to singleaccess for drug administration including hazardous agents. At 1105,attach the syringe assembly according to the embodiments of the presentinvention to a catheter or IV connector on a catheter or Y site access.At 1110, check patency by pulling back on plunger unit. At 1115, attachmedication syringe (with or without closed male luer) to plunger unit.At 1120, infuse medication and remove syringe assembly. At 1125, attachflush syringe and infuse flush solution. At 1030, remove syringeassembly from patient and discard per hospital protocol.

A fourth method detailed in flow chart 1200 of FIG. 29 relates tosyringe assembly pre-filled with a flush solution. At 1205, attach thesyringe assembly according to the embodiments of the present inventionto a catheter or IV connector on a catheter or Y site access. At 1210,check patency by pulling back on plunger unit. At 1215, attachmedication syringe (with or without closed male luer) to plunger unit.At 1220, infuse medication and remove syringe assembly. At 1225, infuseflush solution. At 1230, remove syringe assembly from patient anddiscard per hospital protocol.

In one embodiment of the present invention, the syringe assembly ismanufactured by first assembling the syringe, plunger unit and pistoninto a unit and then mechanically inserting the cannula into placethrough the piston at a first end and proximate a syringe tip opening ata second end. Such a process is more efficient and creates a more stableproduct.

The embodiments of the present invention serve to minimize contaminationrisks by using a closed vascular system. Such systems minimize thepotential for cross-contamination and touch-contamination (e.g., humanfactor during access/de-access) and potential contamination to theinternal structure of the valve (e.g., design flaws). The ratesassociated with such contamination affects hospital CMS reimbursement.By utilizing the pre-filling feature (saline or other fluid) of theembodiments of the present invention, multiple accesses and/or steps todisinfect the valve can be eliminated. By reducing access and de-accesssteps, exposure of the threads and internal compartments is eliminatedmaking a single disinfection adequate prior to line procedures. This isaccomplished because the syringe luer remains engaged and allows theflush solution to expel the blood from the valve prior to removal of thesyringe. This eliminates the opening and reinsertion of a flush syringethus preventing the blood and particulate from finding its way into thenooks and crannies of the mating valve on either a peripheral or centralline. This will greatly reduce blood borne pathogen exposure and reducethe potential for BSI's/CLBSI's.

In one embodiment, the syringe of the embodiments of the presentinvention are compatible with culture bottle and sterile collectiondevices that effectively remove potentially contaminated skin flora in awaste cavity. In other words, routine blood collection can bestandardized to include a culture specimen with the syringe as detailedherein.

In an embodiment having an interface for receipt of a vacutainer in thereceiving cavity, the rubber seal or condom which prevents the flow ofair into the needle of a multi-sample luer adapter is modified such thatthe rubber seal includes a thicker wall near the base or a skirt toprovide an improved air tight seal.

In another embodiment, as shown in FIGS. 30A and 30B, means forpreventing fluids exiting the cannula 1300 into the channel 1305 of theadapter portion 1310 of the plunger unit 1315 are incorporated into thesyringe assembly design. In one embodiment, shown in FIG. 31A, thechannel 1305 is fabricated with such tolerances to minimize the volumebetween the outer surface of the cannula 1300 and the inner surface ofthe channel 1305. In another embodiment, shown in FIG. 31B, an O-ring1350 is attached to the top of the cannula 1300 prevents fluids fromseeping below into the depths of the channel 1305. In other embodiments,the channel 1305 may receive an internal sleeve with a wiper seal,overmold seal on the plunger unit, drop-in insert, etc. In oneembodiment, the sleeve or insert extends from the luer tip to thechannel opening in the receiving cavity. Reducing the available volumein the channel is important when infusing micro/small doses ofmedication and subsequent flushing.

Although the invention has been described in detail with reference toseveral embodiments, additional variations and modifications existwithin the scope and spirit of the invention as described and defined inthe following claims.

We claim:
 1. A syringe assembly comprising: a syringe having acylindrical body with a luer at a first end, said luer having an exitopening; a plunger unit including an adapter portion and a receivingcavity, a first end of said adapter portion retaining a piston, saidplunger unit insertable into a second end of said syringe and slidablewithin said cylindrical body during which said piston creates a sealwith an interior surface of said cylindrical body, said adapter portionincluding a channel extending along its length to an opening at a bottomof said receiving cavity for insertion of an intermediary connector orvalve; and a cannula secured at one end proximate said exit opening ofsaid luer and extending into said piston and extendable into saidchannel as said plunger unit is inserted farther into said syringe, afluid seal separating said cannula from said channel.
 2. The syringeassembly of claim 1 wherein said receiving cavity has a depth in a rangeof about 1 inch to 1.5 inches.
 3. The syringe assembly of claim 1wherein said fluid seal is provided by an O-ring attached to the top ofthe cannula.
 4. The syringe assembly of claim 1 wherein said fluid sealis provided by an internal sleeve with a wiper seal
 5. The syringeassembly of claim 1 wherein said fluid seal is provided by an overmoldseal on said plunger unit
 6. The syringe assembly of claim 1 whereinsaid fluid seal is provided by a drop-in insert into said channel. 7.The syringe assembly of claim 4 wherein said internal sleeve extendsfrom the luer tip to the channel opening in the receiving cavity.
 8. Thesyringe assembly of claim 6 wherein said insert extends from the luertip to the channel opening in the receiving cavity.
 9. A syringeassembly comprising: a syringe having a cylindrical body with a luer ata first end, said luer having an exit opening; a plunger unit includingan adapter portion and a receiving cavity, a first end of said adapterportion retaining a piston, said plunger unit insertable into a secondend of said syringe and slidable within said cylindrical body duringwhich said piston creates a seal with an interior surface of saidcylindrical body, said adapter portion including a channel extendingalong its length to an opening at a bottom of said receiving cavity forinsertion of an intermediary connector or valve; and a cannula securedat one end proximate said exit opening of said luer and extending intosaid piston and extendable into said channel as said plunger unit isinserted farther into said syringe, a seal member within said channel,said seal member serving to reduce the volume of liquid that may entersaid channel.
 10. The syringe assembly of claim 9 wherein said sealmember is an O-ring attached to the top of the cannula.
 11. The syringeassembly of claim 9 wherein said seal member is an internal sleeve witha wiper seal
 12. The syringe assembly of claim 9 wherein said sealmember is a drop-in insert into said channel.
 13. The syringe assemblyof claim 11 wherein said internal sleeve extends from the luer tip tothe channel opening in the receiving cavity.
 14. The syringe assembly ofclaim 12 wherein said insert extends from the luer tip to the channelopening in the receiving cavity.
 15. A syringe assembly comprising: asyringe having a cylindrical body with a luer at a first end, said luerhaving an exit opening; a plunger unit including an adapter portion anda receiving cavity, a first end of said adapter portion retaining apiston, said plunger unit insertable into a second end of said syringeand slidable within said cylindrical body during which said pistoncreates a seal with an interior surface of said cylindrical body, saidadapter portion including a channel extending along its length to anopening at a bottom of said receiving cavity for insertion of anintermediary connector or valve; and means within said channel forreducing the volume of liquid that may enter said channel.
 16. Thesyringe of claim 15 wherein said means within said channel for reducingthe volume of liquid that may enter said channel is selected from thegroup consisting of: an O-ring attached to the top of the cannula, aninternal sleeve with a wiper seal, a drop-in insert and
 17. The syringeassembly of claim 16 wherein said internal sleeve extends from the luertip to the channel opening in the receiving cavity.
 18. The syringeassembly of claim 16 wherein said insert extends from the luer tip tothe channel opening in the receiving cavity.